The Efficacy and Safety of Viscoelastic-Augmented Bleb Needling after Primary Trabeculectomy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250826007

Enrollment

168

Registered

2025-08-26

Start date

2026-01-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleb failure in patient who had undergone primary trabeculectomy within 6 months Viscoelastic, augmentation, bleb needling, trabeculectomy

Interventions

ophthalmic viscosurgical devices (1.8% sodium hyaluronate) with 5-Fluorouracil under bleb injection,5-Fluorouracil under bleb injection

Experimental Device,Active Comparator Procedure/Surgery

ophthalmic viscosurgical devices (1.8% sodium hyaluronate) with 5-Fluorouracil ,Standard bleb needing with 5-Fluorouracil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient aged > 18 years 2. Glaucoma patients who underwent primary trabeculectomy with mitomycin -C, with or without phacoemulsification, within the last 6 months 3. IOP over 21 mmHg 4. No blockage of the sclerostomy 5. Failure to lower IOP using ocular massage and/or laser suture lysis

Exclusion criteria

Exclusion criteria: 1. Allergy to viscoelastic substances, prednisolone acetate, povidone-iodine, 5-FU, or tetracaine used in the study 2. Pregnancy or lactation 3. Decline to participation 4. Patients who undergo non-glaucoma ocular surgeries, including cataract surgery after the first bleb needling

Design outcomes

Primary

Measure	Time frame
Complete success rate at 6 month after first bleb needling after primary trabeculectomy. as percentage from defined criteria	—

Secondary

Measure	Time frame
Qualified success at 6 month after first bleb needling after primary trabeculectomy. as percentage from defined criteria,Failure rate at 6 month after first bleb needling after primary trabeculectomy. as percentage from defined criteria,Intraocular pressure reduction at 6 month after first bleb needling after primary trabeculectomy. as mmHg by Goldmann applanation,Number of antiglaucoma medications at 6 month after first bleb needling after primary trabeculectomy. Number of antiglaucoma medications,Bleb morphology at 6 month after first bleb needling after primary trabeculectomy. Indiana Bleb Appearance Grading Scale (IBAGS) and Anterior Segment Optical Coherence Tomography,Re-needling rate at 6 month after first bleb needling after primary trabeculectomy. percentage and time to re-needling procedure,Complications at 6 month after first bleb needling after primary trabeculectomy. as reported in percentage	—

Measure

Time frame

Qualified success at 6 month after first bleb needling after primary trabeculectomy. as percentage from defined criteria,Failure rate at 6 month after first bleb needling after primary trabeculectomy. as percentage from defined criteria,Intraocular pressure reduction at 6 month after first bleb needling after primary trabeculectomy. as mmHg by Goldmann applanation,Number of antiglaucoma medications at 6 month after first bleb needling after primary trabeculectomy. Number of antiglaucoma medications,Bleb morphology at 6 month after first bleb needling after primary trabeculectomy. Indiana Bleb Appearance Grading Scale (IBAGS) and Anterior Segment Optical Coherence Tomography,Re-needling rate at 6 month after first bleb needling after primary trabeculectomy. percentage and time to re-needling procedure,Complications at 6 month after first bleb needling after primary trabeculectomy. as reported in percentage

—

Countries

Thailand

Contacts

Public ContactKitiya Ratanawongphaibul

Faculty of Medicine, Chulalongkorn University

kitiyaoph@gmail.com6622564142

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026